This week on Pipeline Moves, we kickoff by looking at the termination of a Phase II trial in respiratory syncytial virus. We also investigate an asthma drug that failed to meet a Phase II trial endpoint. On a good note, we review trial completions in ovarian cancer, retinitis pigmentosa, bladder cancer, and chronic kidney disease.

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Pfizer’s Phase II trial termination in RSV

Pfizer’s RV521 (sisunatovir hydrochloride) saw its Phase Transition Success Rate (PTSR) decrease in respiratory syncytial virus (RSV) infections after a Phase II trial in RSV and lower respiratory tract (LRT) infections was terminated.

The drug’s PTSR dropped by 11 points, reaching 49% in RSV infections. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.

The Phase II trial’s (NCT04225897) status was updated from completed to terminated on ClinicalTrials.gov on 26 June, and GlobalData evaluated the asset the next day.

According to the study’s ClinicalTrials.gov listing, Part A and Part B of the trial were completed but Pfizer terminated Part C due to strategic consideration. However, the termination reason was not based on safety concerns or changes to the risk-benefit for subjects who received RV521 treatment.

The multi-centre study evaluated the safety, tolerability, pharmacokinetic and pharmacodynamics and antiviral efficacy of single and multiple dosing of RV521 in infants hospitalised due to RSV and LRT infections. The study recruited 51 infants between the ages of one to 36 months of age that were hospitalised due to a confirmed clinical diagnosis of LRT and RSV infection.

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RV521 is a small molecule that acts by inhibiting the RSV fusion protein, which plays a role in membrane fusion and initiating virus infection. The drug candidate prevents the replication of virus by blocking the activity of RSV fusion protein.

Asthma drug missed Phase II trial endpoint

Avalo Therapeutics‘ AVTX-002 saw its PTSR drop in asthma by 14 points to 10% after the company failed to meet its endpoint in a Phase II trial.

On 26 June, Maryland, US-based Avalo Therapeutics announced its candidate did not meet the trial’s (NCT05288504) primary endpoint measured by reduction in asthma related events compared to placebo. GlobalData evaluated the asset on 27 June.

The randomised, double-blind, placebo-controlled, parallel group study was evaluating the safety and efficacy of AVTX-002 for the treatment of poorly controlled non-eosinophilic asthma. A total of 91 patients were enrolled. Subjects were administered with 600 mg of the candidate or placebo at day 0, 28 and 56. Safety and efficacy were evaluated 12 weeks after treatment.

AVTX-002 is a LIGHT (homologous to lymphotoxin, exhibits inducible expression and competes with HSV glycoprotein D for binding to herpesvirus entry mediator, a receptor expressed on T lymphocytes) ligand inhibitor.

Completion of Phase II ovarian cancer trial

Corcept Therapeutics’ relacorilant saw a 16-point increase in its PTSR, settling at 53% in metastatic ovarian cancer following the release of Phase II results.

The California, US-based company released results (NCT03776812) in a 27 June press release and GlobalData evaluated the asset on the following day. 

The open-label, randomised, three-arm Phase II study investigated the progression-free survival (PFS) in patients with recurrent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer treated with intermittent or continuous regimens of relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel alone.

Relacorilant is a non-steroidal, selective, glucocorticoid receptor antagonist that inhibits receptor activity, leading to cancer cell apoptosis. The therapy is also being developed as a treatment for Cushing’s syndrome and several other cancers.

Phase II retinitis pigmentosa trial completion

Aldeyra Therapeutics’ ADX-2191 saw its PTSR increase in retinitis pigmentosa after the completion of a Phase II trial. The drug’s PTSR grew by 15 points to 64%.

The status of the Phase II trial (NCT05392179) was updated from active, not recruiting to completed on ClinicalTrials.gov on 30 June, and GlobalData evaluated the asset on 3 July. The purpose of this multi-centre study was to assess the safety of ADX-2191 in subjects with retinitis pigmentosa. The trial enrolled eight patients.

ADX-2191 is an intravitreal injection formulation of methotrexate. Methotrexate is a competitive inhibitor of dihydrofolate reductase (DHFR) leading to inhibition of DNA synthesis. ADX-2191 is under development for the treatment of proliferative vitreoretinopathy (PVR), primary vitreoretinal lymphoma and retinal detachment. 

Phase I trial completion in bladder cancer

Vyriad’s MV-NIS vaccine (Oncolytic Virus to Target CD46 and SLC5A5 for Oncology) saw its PTSR increase in bladder cancer after a Phase I trial in urothelial carcinoma was completed. The drug’s PTSR increased by 21 points, reaching 74% in bladder cancer.

The status of the Phase I trial (NCT03171493) was updated from active, not recruiting to completed on ClinicalTrials.gov on 27 June, and GlobalData evaluated the asset on the next day.

The open-label study evaluated the tolerability and feasibility of intravesical therapy with an attenuated measles virus (MV-NIS) in patients suffering from urothelial carcinoma. The study recruited eight adult participants with a confirmed urothelial carcinoma diagnosis undergoing radical cystectomy but not eligible or do not desire to receive neoadjuvant chemotherapy.

The asset is under development for the treatment of recurrent ovarian epithelial cancer, primary peritoneal cancer, endometrial cancer, recurrent squamous cell carcinoma, as well as head and neck cancer among others.

The candidate contains attenuated oncolytic Edmonston (Ed) strain of the measles virus encoding the human thyroidal sodium iodide symporter (MV-NIS). MV-NIS attacks cells expressing the human CD46 antigen- which is overexpressed in cancer cells- and induces tumor cell lysis.

Healthy-subject Phase I trial completion in CKD

Urica Therapeutics’s dotinurad saw its PTSR rise in chronic kidney disease (CKD) by 15 points, settling at 65%, following the release of Phase I data.

The Phase I study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of dotinurad in healthy subjects. Data demonstrated that the drug was safe and well tolerated with no severe adverse events observed for any doses throughout the trial.

Dotinurad is a novel urate transporter (URAT1) inhibitor that lowers blood uric acid levels by selectively inhibiting URAT1 and uric acid reabsorption in the kidney. The drug received approval as a once-daily oral therapy to treat hyperuricaemia with or without gout in Japan in 2020. The drug is marketed under the brand name Urece.

Read the last edition:

Pipeline Moves: Advancement prospects fall for GM1 gene therapy after trial termination

Need to know:

GlobalData’s proprietary model uses a combination of machine learning and an algorithm to calculate an individual drug’s PTSR and LoA. While LoA provides the probability of a drug ultimately receiving market authorization, PTSR indicates the probability of a drug’s advancement to the next stage of clinical development. The model uses datapoints from individual drugs, clinical trials, regulatory milestones, company, and financial databases.